Quality Project Engineer
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Job Location:
Monthly Salary:
Posted on:
19 hours ago
Vacancies:
1 Vacancy
Job Summary
At Beiersdorf we want to help people feel good about their skin and our commitment goes far beyond caring for skin. For 140 years we have developed innovative skin and body care products for well-known brands such as NIVEA Eucerin La Prairie Hansaplast and Labello. We act according to our purpose WE CARE BEYOND SKIN and take responsibility for our consumers our employees the environment and society.
Behind every brand every product and every accomplishment are our more than 20000 employees. It is for them that we live an inclusive culture of respect and trust that is strongly aligned with our values CARE COURAGE SIMPLICITY and TRUST. We also embrace diversity by valuing the uniqueness of each individual and being committed to equal opportunities for all.
Your Tasks
Ensure the proper planning documentation evaluation and execution of change control design review commissioning qualification and validation processes for equipment facilities computerized systems and critical systems within projects at a regulated manufacturing plant (OTC and cosmetics) ensuring compliance with applicable national and international regulations and the Quality Management System.
Key Responsibilities
Evaluate and approve URS FAT/SAT protocols commissioning and qualification/validation activities for equipment facilities and critical systems.
Prepare review and ensure compliance of qualification and validation protocols in accordance with GMP and international standards (ISO GAMP 5 CFR 21 Part 11 WHO among others).
Manage and maintain project documentation related to the Quality Management System.
Manage and follow up on change controls ensuring GMP compliance.
Participate in internal and external quality audits providing technical support and responses.
Coordinate and participate in quality risk assessments for assigned projects.
Update and/or develop procedures aligned with applicable regulations and plant requirements.
Ensure compliance with environmental health and safety policies.
If applicable manage direct reports by conducting performance evaluations providing feedback setting objectives monitoring KPIs and following up on annual training plans.
Your Profile
Minimum of 4 years of experience in validation and quality projects within the cosmetic and/or pharmaceutical industry.
Experience with manufacturing and filling equipment for liquid and semi-solid products.
Knowledge of the lifecycle of equipment facilities and critical systems.
Experience with Quality Management Systems (GxP CAPA deviations change control).
- Education: Bachelors degree in Pharmaceutical Chemistry (QFB/QFI) Chemical Engineering Biochemistry Biotechnology or related field.
- English : Advance
Technical Knowledge
Good Documentation Practices (GDP).
Regulations: COFEPRIS FDA Health Canada.
Guidelines and standards: GAMP 5 ISO 14644 ISO 8573 ICH ISPE WHO.
Quality risk assessment and project management.
Competencies
Integrity
Decision-making
Strategic vision
Leadership
Required Experience:
IC
Key Skills
- Administrative Skills
- General Services
- Commercial
- Hibernate
- Airport
- Archicad
About Company
We care for skin, we care for people and we care beyond skin. That is what makes us unique.
